Bring Your Own Device for Trial Outcome Assessment
Survey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
‘Breakthrough’ Program Generates Optimism — and Concerns
FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.
Antibiotic-Resistance Focus Could Benefit Clinical Trials
Renewed attention on ways to tackle this age-old scourge is building in Europe and beyond.
EFGCP Renews Campaign on Older People in Research
European forum tackles the problem of limited elderly patients involved in clinical trials.
Paperless Processes on the Way Out?
Survey reveals mixed adoption of paperless data collection in clinical trials, pointing to the need for greater alignment of new eClinical technologies and study conduct.
EHR eSource: Sword of Change?
Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.
Critical Update to Cardiac Safety Assessments
CDER official comments on the significance of ICH's new alternative path for identifying the cardiac safety issue of QT prolongation in non-cardiac drugs.
Regulatory Considerations are Key in eSource Data Integration
The need to involve regulators is crucial when the use of electronic data devices impacts the management of patient safety and evaluation of trial endpoints.
Engagement Shift: Informed Consent in the Digital Era
Why electronic informed consent is key to supporting today’s patient-centric mantra in clinical trials.
Emphasizing ‘Solutions’ in eClinical Tools for Sites
Work burden and performance hurt by technology incompatibility.
Quality Remote Monitoring: The Tools of the Game
Outlining those technologies best able to raise the data and process quality of risk-based monitoring.
Applied Clinical Trials, June/July 2016 Issue (PDF)
Click the title above to open the Applied Clinical Trials June/July 2016 issue in an interactive PDF format.